An in vitro diagnostic test for the detection of HIV-1 genomic drug resistance mutations (DRMs) will hit the market soon.
Called Sentosa SQ HIV-1 Genotyping Assay, the test uses the plasma of patients infected with HIV-1 to detect HIV-1 Group M DRMs in the protease, reverse transcriptase, and integrase regions of the pol gene, in a single test.
It is the first and only HIV-1 genotyping NGS assay currently available on the market to receive marketing authorization from the USFDA, according to Vela Diagnostics.
The system uses a standalone version of the curated Stanford University HIV Drug Resistance Database to ensure traceability of the DRM interpretation report. It can provide information on drug resistances associated with the detected mutations.
Resistance of HIV-1 to antiretroviral drugs as a result of DRMs is the most common cause of therapeutic failure in patients with HIV-1 infection.